WO2016179727A1

WO2016179727A1 - Orthopedic implant with polymer-wrapped metal prosthesis

Info

Publication number: WO2016179727A1
Application number: PCT/CN2015/000722
Authority: WO
Inventors: 朱健; 徐龙伟
Original assignee: 江苏奥康尼医疗科技发展有限公司
Priority date: 2015-05-08
Filing date: 2015-10-28
Publication date: 2016-11-17
Also published as: CN105031745B; CN105031745A

Abstract

An orthopedic implant with a polymer-wrapped metal prosthesis, comprising a metal implant body and a high-molecular layer wrapping the surface of the implant. The orthopedic implant is formed by wrapping the surface of a metal implant body material with an anti-corrosion organic high-molecular material, such that a metal implant is prevented from being corroded by human body liquid. An organic high-molecular material wraps between two metal implants in contact with each other, so that contact between metal and metal is prevented, thereby inhibiting electrochemical reactions caused by the contact between metal and metal, and further reducing adverse reactions on a human body caused by dissolution of metal ions. Meanwhile, the existence of a high-molecular interface aids in enhancement of locking between metal implants, prevents and reduces slight movement, and accelerates operation healing.

Description

Orthopedic implant with metal-coated prosthesis

Technical field

The present invention relates to a medical rehabilitation device, and more particularly to an orthopedic implant in which a metal prosthesis is wrapped with a polymer.

Background technique

Metal materials are one of the most commonly used materials for orthopedic implants. Metal materials have advantages such as high strength and good toughness, and are not widely used in ceramics and polymer materials. Therefore, they are widely used in structural components of orthopedic implants with high strength requirements, such as bone plates, intramedullary nails, bone screws, and joints. Handle, femoral condyle, etc. The most commonly used metal materials are titanium and titanium alloys, CoCrMo alloys, stainless steels, etc. (Pezzotti G, Yamamoto K. Artificial hip joints: The biomaterials challenge. J Mech Behav Biomed Mater. 2014 Mar; 31: 3-20). However, metal materials can cause different degrees of corrosion when in contact with human liquids. Corrosive substances include metal ions, which can cause adverse reactions in the human body. Therefore, reducing or preventing corrosion of implants in metal orthopedics is its application. A basic requirement (Matusiewicz H, Potential release of in vivo trace metals from metallic medical implants in the human body: from ions to nanoparticles - a systematic analytical review, Acta Biomater. 2014 Jun; 10(6): 2379-403).

In addition, the corrosion of metals in body fluids is more severe in the state of fretting wear (Engh CA Jr, Ho H, Padgett DE. The surgical options and clinical evidence for treatment of wear or corrosion occurrence with THA or TKA. Clin Orthop Relat Res.2014Dec;472(12):3674-86). For example, the joint of the bone plate and the screw, the joint of the intramedullary nail and the interlocking screw, and the joint of the spinal screw and the elastic rod (Brown SA, Hughes PJ, Merritt K. In vitro studies of fretting corrosion of orthopaedic materials. J Orthop Res. 1988; 6(4): 572-9), the joint between the joint and the ball head (Esposito CI, Wright TM, Goodman SB, Berry DJ, What is the trouble with trunnions? Clinical, Biological and Bioengineering Study Groups from Carl T. Brighton Workshop. Clin Orthop Relat Res. 2014 Dec; 472(12): 3652-8), between the acetabular cup and the lining (Agne MT, Underwood RJ, Kocagoz SB, MacDonald DW, Day JS, Parvizi J, Kraay MJ, Mont MA, Klein GR, Cates HE, Kurtz SM, Is there material loss at the backside taper in modular CoCr acetabular liners? Clin Orthop Relat Res.2015Jan;473(1):275 -85), the joint of the acetabular cup and the screw (Kligman M, Furman BD, Padgett DE, Wright TM. Impingement contributes to backside wear and screw-metallic shell fretting in modular acetabular cups. J Arthroplasty. 2007 Feb; 22 (2) : 258-64), the joint between the tibial plateau and the screw, and any other metal-to-metal joints, which are the most prone to corrosion. Therefore, how to prevent or reduce the corrosion of the metal-to-metal contact surface is also a problem that needs to be further solved. The present invention is primarily directed to non-sliding surfaces, so wear resistance is not critical. For metal-to-metal non-sliding interfaces, the presence of a polymer interface helps to strengthen the lock, preventing and reducing fretting.

Summary of the invention

In order to solve the above problems and drawbacks, it is an object of the present invention to provide an orthopedic implant that wraps a metal prosthesis with a polymer. The orthopedic implant reduces the corrosion of the inner implant by coating the surface of the metal orthopedic implant with an organic polymer material; coating the metal implants in contact with each other with an organic polymer material can prevent The contact between metal and metal further inhibits the electrochemical reaction of metal to metal contact, thereby reducing the adverse reaction of metal ion dissolution on the human body, further inhibiting the toxic effect of metal ions on the human body; The presence helps to strengthen the locking between the metal implants, preventing and reducing fretting and accelerating surgical healing.

In order to achieve the above object, the present invention adopts the following technical solutions:

An orthopaedic implant for wrapping a metal prosthesis with a polymer, comprising a metal implant body and a polymeric layer coated on the surface of the implant.

Further, the orthopedic implant includes a bone plate, a bone screw, an intramedullary nail, a spinal fixation nail, a hip joint, an acetabular cup, a knee joint femoral condyle, and a knee joint tibial plateau.

Further, the material of the metal implant body is selected from the group consisting of titanium, titanium alloy, cobalt chromium molybdenum alloy, and stainless steel.

Further, the material of the polymer layer is selected from the group consisting of polyetheretherketone, polyetheretherketone derivatives, polytetrafluoroethylene, polytetrafluoroethylene derivatives, ultrahigh molecular polyethylene, and ultrahigh molecular polyethylene. derivative.

Further, the polymer layer has a thickness ranging from 1 to 2000 μm.

Further, the polymer layer has a thickness ranging from 10 to 1000 μm.

Further, the polymer layer is only coated on the surface of the metal implant combined with another metal implant.

Further, the polymer layer completely encapsulates the metal implant.

Further, the surface of the metal implant body is a porous structure, and the outer surface of the polymer layer is also a porous structure.

Further, the polymer layer is formed by a thermal spraying technique, a chemical deposition technique, an electrochemical deposition technique, or an injection molding technique.

Due to the above technical solution, the present invention has the following advantages compared with the prior art:

The inner implant of the present invention is coated on the surface of the metal implant body material by using a corrosion-resistant organic polymer material, thereby preventing corrosion of the metal implant by the human body liquid; The organic polymer material is coated between the metal implants to prevent the metal from contacting the metal, further suppressing the electrochemical reaction of the metal to the metal contact, thereby reducing the adverse reaction of the metal ion to the human body.

DRAWINGS

1 is a schematic structural view of a bone-containing plate containing a wrap of an orthopedic implant of the present invention;

2 is a schematic structural view of a hip joint of an orthopedic implant of the present invention;

Figure 3 is a schematic view showing the structure of an intramedullary nail of the orthopedic implant of the present invention;

Figure 4 is a schematic view showing the structure of a spinal fixation nail rod of the orthopedic implant of the present invention;

Figure 5 is a schematic view showing the structure of a femoral condyle of the orthopedic implant of the present invention;

Figure 6 is a schematic view showing the structure of a bone screw of the orthopedic implant of the present invention;

Figure 7 is a schematic view showing the structure of the tibial tray of the orthopedic implant of the present invention.

detailed description

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

The orthopedic implants of the present invention with polymer-wrapped metal prostheses include, but are not limited to, implants for securing and protecting the human body, such as bone plates, bone screws, intramedullary nails, interlocking screws, spinal screws, elastic Rods, etc.; can also be artificial joints and some of them, such as hip joints, acetabular cups, knee joint femurs, and knee joints.

The material of the implant body of the orthopedic implant of the present invention using a polymer-wrapped metal prosthesis is a medical metal material including, but not limited to, titanium, titanium alloy, cobalt chromium molybdenum alloy, stainless steel, and the like.

The implant of the orthopedic implant with a polymer-wrapped metal prosthesis of the present invention is coated with a layer of an organic polymer material on the surface of the metal implant body, which prevents the human body from liquid metal implants. Corrosion of the bulk of the material, including but not limited to polyetheretherketone (PEEK), polyetheretherketone derivatives, polyetheretherketone composites, polytetrafluoroethylene (PTFE), polytetrafluoroethylene Derivatives, ultra-high molecular polyethylene (UHMWPE) and derivatives of ultra-high molecular polyethylene. The organic polymer material coating layer may be formed on the surface of the metal implant body by, for example, thermal spraying technology, chemical deposition technique, electrochemical deposition technique, or injection molding technique.

In a preferred embodiment, the polymeric layer has a thickness in the range of from 1 to 2000 microns, preferably in the range of from 10 to 1000 microns. If the thickness of the coating layer is less than 10 micrometers, tiny surface defects may cause leakage and pitting corrosion of the base metal; if the thickness of the coating layer is greater than 1000 micrometers, the overall strength and rigidity of the wrapped interior may vary greatly. .

In a preferred embodiment, the metal orthopedic implant applied in an environment where the human body is not corroded by the human body may be partially covered, that is, only one metal implant and another gold The bonding sites where the implants are in contact with each other coat the organic polymer layer to prevent the metal from contacting the metal to form an electrochemical reaction to corrode the metal implant. For the metal orthopedic implants used in the environment where the human body is corroded more severely, the completely coated method can be adopted, that is, the outer surface of the implant body in the metal orthopedics is completely coated with the organic polymer layer.

In a preferred embodiment, the surface of the metal implant body is a porous structure, and the porous structure can enhance the bonding force between the implant body and the organic polymer coating layer, thereby coating the organic polymer in subsequent use. The layer does not peel off the implant body. The outer surface of the polymer layer is also a porous structure. The porous structure can be obtained by mechanical treatment or structural treatment. A surface of the porous structure can also be superimposed with a micro-rough surface, and the micro-rough surface can be obtained by chemical treatment. The porous and rough surface allows the bone tissue to grow in, thereby making the combination of the organic polymer coating and the human bone tissue stronger, and increasing the durability of the implant.

The above is only the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. The invention is intended to be modified or equivalently substituted without departing from the spirit and scope of the invention. Within the scope of protection.

Claims

An orthopaedic implant for wrapping a metal prosthesis with a polymer, comprising a metal implant body and a polymeric layer coated on the surface of the implant.
The intraosseous implant with a polymer-wrapped metal prosthesis according to claim 1, wherein the orthopedic implant comprises a bone plate, a bone screw, an intramedullary nail, a spinal fixation nail, and a hip joint. Handle, acetabular cup, knee femoral condyle, and knee tibial plateau.
The orthopedic implant of a metal-coated prosthesis according to claim 1, wherein the material of the metal implant body is selected from the group consisting of titanium, titanium alloy, cobalt chromium molybdenum alloy, and stainless steel.
The orthopedic implant with a polymer-coated metal prosthesis according to claim 1, wherein the material of the polymer layer is selected from the group consisting of polyetheretherketone, polyetheretherketone derivatives, and polytetrafluoroethylene. Derivatives of ethylene, polytetrafluoroethylene, ultrahigh molecular weight polyethylene, and ultrahigh molecular weight polyethylene.
The orthopedic implant of a metal-coated prosthesis according to claim 1, wherein the polymer layer has a thickness ranging from 1 to 2000 microns.
The orthopedic implant of a metal-coated prosthesis according to claim 5, wherein the polymer layer has a thickness in the range of 10 to 1000 μm.
The orthopedic implant of a metal-coated prosthesis according to claim 1, wherein the polymer layer covers only a surface of the metal implant combined with another metal implant.
The orthopedic implant of a metal-coated prosthesis according to claim 1, wherein the polymeric layer completely encapsulates the metal implant.
The orthopedic implant with a polymer-coated metal prosthesis according to claim 1, wherein the surface of the metal implant body is a porous structure, and the outer surface of the polymer layer is also a porous structure. .
The orthopedics of a metal-coated prosthesis wrapped with a polymer according to any of claims 1-9 An implant characterized in that the polymer layer is formed by a thermal spray technique, a chemical deposition technique, an electrochemical deposition technique, or an injection molding technique.